A. Mottrie

The Role of Laparoscopic and Robotic Cystectomy in the Management of Muscle-Invasive Bladder Cancer With Special Emphasis on Cancer Control and Complications

CONTEXT Minimally invasive radical cystectomy (MIRC) techniques for the treatment of muscle-invasive bladder cancer (BCa) are being increasingly applied. MIRC offers the potential benefits of a minimally invasive approach in terms of reduced blood loss and analgesic requirements whilst striving to provide similar oncologic efficacy to open radical cystectomy (ORC). Whether quicker recovery, shorter hospital stay, and a reduction in complications are routinely achieved with MIRC remains to be proved in prospective comparisons. OBJECTIVE To explore both laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RRC), focusing specifically on the oncologic parameters and comorbidity of the procedures. Reported complications from major centres are identified and categorised via the Clavien system. Positive margins rates, local recurrence, and both cancer-specific survival (CSS) and overall survival rates are assessed. EVIDENCE ACQUISITION A comprehensive electronic literature search was conducted in November 2010 using the Medline database to identify publications relating to laparoscopic, robotic, or minimally invasive radical cystectomy. EVIDENCE SYNTHESIS There are encouraging short- to medium-term results for both LRC and RRC in terms of postoperative morbidity and oncologic outcomes. It seems possible in experienced hands to perform a satisfactory minimally invasive lymphadenectomy regarding lymph node counts and levels of dissection. Positive soft-tissue margins are similar to large open series for T2/T3 disease but inferior for bulky T4 disease. Local recurrence rates and CSS rates seem equivalent to ORC at up to 3 yr of follow-up; however, mature outcome data still need to be presented before definitive comparisons can be made. CONCLUSIONS Robotic and laparoscopic cystectomy has a growing role in the management of muscle-invasive BCa. Long-term oncologic results are awaited, and there are concerns over the ability of MIRC to treat bulky and locally advanced disease, making careful patient selection vital. Forthcoming randomised trials in this area will more fully address these issues.

Predictors of warm ischemia time and perioperative complications in a multicenter, international series of robot-assisted partial nephrectomy.

BACKGROUND Warm ischemia time (WIT) and complication rates are two important parameters for evaluating the perioperative results of robot-assisted partial nephrectomy (RAPN). Few data are available about the clinical predictors of WIT and overall complications. OBJECTIVE To identify clinical predictors of WIT and perioperative complications. DESIGN, SETTING, AND PARTICIPANTS This is a retrospective study including 347 patients who underwent RAPN for suspicious renal cell carcinoma (RCC) at four referral centers from September 2008 to September 2010. INTERVENTION All patients underwent RAPN using the da Vinci S Surgical System with hilar clamping. MEASUREMENTS WIT >20 min and overall complication rates were the main outcomes. Postoperative complications were classified according to the Clavien/Dindo system. Moreover, the following perioperative variables were considered: clinical tumor size, anatomical tumor characteristics according to Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) classification score, surgeon experience, console time, blood loss, and upper collecting system (UCS) repair. RESULTS AND LIMITATIONS WIT >20 min was reported in 125 (36%) cases. Intraoperative and postoperative complications were observed in 10 (2.9%) and 41 (11.8%) cases, respectively. Surgeon experience (odds ratio [OR]: 6.381; 95% confidence interval [CI], 3.687-11.042; p<0.001), clinical tumor size (OR: 1.022; 95% CI, 1.002-1.044; p=0.03), the other anatomic characteristics determined by the PADUA classification score (OR: 1.294; 95% CI, 1.080-1.549; p=0.005), and the UCS repair (OR: 2.987; 95% CI, 1.728-5.165; p<0.001) turned out to be independent predictors of WIT >20 min. Similarly, surgeon experience (OR: 3.937; 95% CI, 2.011-7.705; p<0.001), clinical tumor size (OR: 1.033; 95% CI, 1.009-1.058; p=0.007), and the other anatomical characteristics determined by the PADUA classification score (OR: 1.427; 95% CI, 1.149-1.773; p<0.001) turned out to be independent predictors of overall complication rates. The retrospective design is the main limitation of this multicenter, international study. Therefore, some patient characteristics and comorbidities were not recorded. CONCLUSIONS Anatomic tumor characteristics as determined by the PADUA classification score were independent predictors of WIT and overall complications, once adjusted for the effects of surgeon experience and clinical tumor size.

Systematic review of methods for reporting combined outcomes after radical prostatectomy and proposal of a novel system: the survival, continence, and potency (SCP) classification.

CONTEXT Although oncologic results remain the main outcome assessment for radical prostatectomy (RP), there is a need to include both urinary continence and potency recovery in the assessment of success for this procedure. Unfortunately, the widely used trifecta system does not weigh these outcomes differently. Moreover, the trifecta system-and even more so, the recently described pentafecta system-is only applicable in preoperatively continent and potent patients who receive bilateral nerve-sparing RP, and thus it is not an appropriate reporting tool for the majority of patients undergoing RP. OBJECTIVE Perform a systematic review to evaluate critically the trifecta and pentafecta models and describe a novel system that can be used to report the most relevant intermediate- and long-term outcomes after RP. This system has increased generalizability by being applicable to all patients undergoing RP. EVIDENCE ACQUISITION A literature search was performed in March 2011 using the Medline, Embase, and Web of Science databases. The Medline search included only a free-text protocol using the terms radical prostatectomy, trifecta, and pentafecta across the Title and Abstract fields of the records. Subsequently, the following limits were used: humans, gender (male), and language (English). The searches of the Embase and Web of Science databases used the same free-text protocol and the same keywords, applying no limits. EVIDENCE SYNTHESIS Eleven original articles reported trifecta outcomes, and only one original article used the pentafecta model. These systems were correctly applied in only 28-62% of treated patients. A mean of 57% (range: 20-83%) of patients achieved continence and potency without prostate-specific antigen failure after RP. All the original articles were surgical series (level 4 evidence). The new proposed system categorizes the three outcomes using the letter S for biochemical disease-free survival, the letter C for urinary continence, and the letter P for potency recovery. This SCP system can be applied to all patients who undergo RP and is thus analogous to the use of the TNM system for classifying disease stage. Moreover, the SCP system allows us to distinguish four different clinical scenarios: (1) oncologic and functional success, (2) oncologic success and functional failure, (3) oncologic failure and functional success, and (4) oncologic and functional failure. CONCLUSIONS The proposed novel SCP system offers the opportunity to appropriately classify all patients who undergo RP according to the oncologic and functional outcomes of relevance to them on an individual basis. We contend that this systems greater generalizability may make it more useful than the currently used trifecta and pentafecta systems, though its validation remains to be performed.

A multicentre matched‐pair analysis comparing robot‐assisted versus open partial nephrectomy

To compare the perioperative, pathological and functional outcomes in two contemporary, large series of patients in different institutions and who underwent open partial nephrectomy (OPN) or robot‐assisted PN (RAPN) for suspected renal tumours.

Long-term biochemical recurrence rates after robot-assisted radical prostatectomy: analysis of a single-center series of patients with a minimum follow-up of 5 years.

OBJECTIVE To address the long-term biochemical recurrence (BCR)-free survival rates of patients treated with robotic-assisted laparoscopic prostatectomy (RALP) with a minimum follow-up of 5 years. MATERIALS AND METHODS Prospectively collected data of 184 patients treated with RALP at a single institution were analyzed. Kaplan-Meier and life tables analyses targeted the rates of BCR according to pathologic parameters. Cox regression analyses addressed predictors of BCR. RESULTS Median follow-up was 67.5 months. One and 10 patients died of prostate cancer (PCa) and other causes, respectively. Mean time to BCR was 83.8 months. The 3-, 5-, and 7-year BCR-free survival rates were 94%, 86%, and 81%, respectively. These rates were 97%, 93%, and 85% for pT2 disease; 94%, 84%, and 84% for pT3a; and 69%, 43%, and 43% for pT3b (P<.001). The same figures were 97%, 90%, and 88% for Gleason sum 6 or lower; 90%, 86%, and 75% for Gleason sum 7; and 85%, 65%, and 65% for Gleason sum 8-10 (P=.01). At univariable analyses, prostate-specific antigen, pathologic Gleason score, and presence of extracapsular extension, seminal vesicle invasion, and adjuvant radiotherapy were significantly associated with BCR. At multivariable analysis, the presence of seminal vesicle invasion and the presence of Gleason sum 8-10 represented independent predictors of BCR (HR=5.14; P=.004 and HR=3.04; P=.04, respectively). CONCLUSION We report the longest available follow-up in RALP patients. RALP represents an oncologically effective procedure. Our oncological results support the increasing diffusion of RALP for the treatment of organ-confined PCa.

Perioperative Outcomes of Robotic and Laparoscopic Simple Prostatectomy: A European-American Multi-institutional Analysis

BACKGROUND Laparoscopic and robotic simple prostatectomy (SP) have been introduced with the aim of reducing the morbidity of the standard open technique. OBJECTIVE To report a large multi-institutional series of minimally invasive SP (MISP). DESIGN, SETTING, AND PARTICIPANTS Consecutive cases of MISP done for the treatment of bladder outlet obstruction (BOO) due to benign prostatic enlargement (BPE) between 2000 and 2014 at 23 participating institutions in the Americas and Europe were included in this retrospective analysis. INTERVENTION Laparoscopic or robotic SP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Demographic data and main perioperative outcomes were gathered and analyzed. A multivariable analysis was conducted to identify factors associated with a favorable trifecta outcome, arbitrarily defined as a combination of the following postoperative events: International Prostate Symptom Score <8, maximum flow rate >15ml/s, and no perioperative complications. RESULTS AND LIMITATIONS Overall, 1330 consecutive cases were analyzed, including 487 robotic (36.6%) and 843 laparoscopic (63.4%) SP cases. Median overall prostate volume was 100ml (range: 89-128). Median estimated blood loss was 200ml (range: 150-300). An intraoperative transfusion was required in 3.5% of cases, an intraoperative complication was recorded in 2.2% of cases, and the conversion rate was 3%. Median length of stay was 4 d (range: 3-5). On pathology, prostate cancer was found in 4% of cases. Overall postoperative complication rate was 10.6%, mostly of low grade. At a median follow-up of 12 mo, a significant improvement was observed for subjective and objective indicators of BOO. Trifecta outcome was not significantly influenced by the type of procedure (robotic vs laparoscopic; p=0.136; odds ratio [OR]: 1.6; 95% confidence interval [CI], 0.8-2.9), whereas operative time (p=0.01; OR: 0.9; 95% CI, 0.9-1.0) and estimated blood loss (p=0.03; OR: 0.9; 95% CI, 0.9-1.0) were the only two significant factors. Retrospective study design, lack of a control arm, and limited follow-up represent major limitations of the present analysis. CONCLUSIONS This study provides the largest outcome analysis reported for MISP for BOO/BPE. These findings confirm that SP can be safely and effectively performed in a minimally invasive fashion in a variety of healthcare settings in which specific surgical expertise and technology is available. MISP can be considered a viable surgical treatment in cases of large prostatic adenomas. The use of robotic technology for this indication can be considered in centers that have a robotic program in place for other urologic indications. PATIENT SUMMARY Analysis of a large data set from multiple institutions shows that surgical removal of symptomatic large prostatic adenomas can be carried out with good outcomes by using robot-assisted laparoscopy.

Long‐term evaluation of survival, continence and potency (SCP) outcomes after robot‐assisted radical prostatectomy (RARP)

To report combined oncological and functional outcome in a series of patients who underwent robot‐assisted radical prostatectomy (RARP) for clinically localised prostate cancer in a single European centre after 5‐year minimum follow‐up according to survival, continence and potency (SCP) outcomes.

Age-adjusted validation of the most stringent criteria for active surveillance in low-risk prostate cancer patients.

The authors tested the performance of the currently used clinical criteria reported in populations studied by van den Bergh et al and Carter et al for the selection of patients with prostate cancer (PCa) for active surveillance (AS) according to age.

Methods and Priorities of Robotic Surgery Training Program

Robotic surgery has emerged as a new technology over the last decade and has brought with it new challenges, particularly in terms of teaching and training. As with the introduction of any new surgical technology, a structured training program has to be developed to ensure better surgical outcomes and patient safety, whichmust not be compromised during the learning process. A wellorganized educational curriculum as well as proficiencybased credentialing processes are required to ensure the safe and efficacious clinical application of new technologies. To date, there are no validated training programs for robotic surgery. The aim of this editorial is to develop a proposal for a validated and structured training curriculum and to carry out validation of this curriculum for robotic fellows. In our opinion, the right curriculum design should include good knowledge development, skills training (dry and wet laboratories), real-life case observation in a training center, bedside assistance, and a mentoring console. The trainees must understand robotic technology. It is essential to become familiar with the tool, the da Vinci Surgical System, which is currently the only commercially available robotic surgery platform. The trainee has to be educated about the device parameters and functions and, more important, instructed on basic troubleshooting and limitations of the system. The right educational curriculum should begin with practical skills training. To increase the knowledge of robotic technology, highly intensive dry and wet laboratory training should be undertaken. Several simulators are now available to increase robotic skills, and good exercises for dry lab training are defined during European Association of Urology (EAU) ‘‘HOT’’ courses [1]. The dry lab guarantees good coordination development and allows trainees to start getting in touch with the instruments. In such a context, bimanuality, dissection, and suturing techniques are easily developed. The main disadvantages of this training strategy relate to the lack of bleeding and the fact that surgical procedures often are not reproducible, as they are in the laboratory. The best way to simulate technical procedures is in the wet lab. Few dedicated training centers are available around Europe, but new technology can be developed with animal models. The wet lab provides a good simulator of procedures, allowing surgical skills to be developed and scientific models to be studied. The main disadvantages relate to the high cost of such teaching models, the large numbers of animals that need to be sacrificed, and the requirements of ethics committees. Moreover, surgical procedures are reproducible but with different anatomic characteristics. Before starting with real-life case observation, highvolume robotic training centers should be identified by the EAU to guarantee real-life case observation in qualified centers. The tips and tricks of each procedure must be shown during live surgery, and different techniques should be discussed with mentors. Bedside assistancemust be considered as the first step to get in touch with real-life procedures. The tips and tricks developed during bedside assisting are very important to gain complete knowledge of the procedure. Moreover, the console surgeon will rely on the future assistants to help solve problems at the bedside. Modular training is the best way to learn how to perform a procedure, reducing performance time and complications [2]. The procedure must be divided into steps, and the EU RO P E AN URO LOG Y 6 5 ( 2 0 1 4 ) 1 – 2

EAU policy on live surgery events.

CONTEXT Live surgery is an important part of surgical education, with an increase in the number of live surgery events (LSEs) at meetings despite controversy about their real educational value, risks to patient safety, and conflicts of interest. OBJECTIVE To provide a European Association of Urology (EAU) policy on LSEs to regulate their organisation during urologic meetings. EVIDENCE ACQUISITION The project was carried out in phases: a systematic literature review generating key questions, surveys sent to Live Surgery Panel members, and Internet- and panel-based consensus finding using the Delphi process to agree on and formulate a policy. EVIDENCE SYNTHESIS The EAU will endorse LSEs, provided that the EAU Code of Conduct for live surgery and all organisational requirements are followed. Outcome data must be submitted to an EAU Web-based registry and complications reported using the revised Martin criteria. Regular audits will take place to evaluate compliance as well as the educational role of live surgery. CONCLUSIONS This policy represents the consensus view of an expert panel established to advise the EAU. The EAU recognises the educational role of live surgery and endorses live case demonstration at urologic meetings that are conducted within a clearly defined regulatory framework. The overriding principle is that patient safety must take priority over all other considerations in the conduct of live surgery. PATIENT SUMMARY Controversy exists regarding the true educational value of live surgical demonstrations on patients at surgical meetings. An EAU committee of experts developed a policy on how best to conduct live surgery at urologic meetings. The key principle is to ensure safety for every patient, including a code of conduct and checklist for live surgery, specific rules for how the surgery is organised and performed, and how each patients results are reported to the EAU. For detailed information, please visit www.uroweb.org.